1. Field of the Invention
This invention relates generally to systems, methods, and computer products for clinical information capture and management and specifically to systems and processes by which electronic medical records may be created and modified in the clinical environment of a patient encounter.
2. Discussion of the Background
An average patient load for a medical specialist such as an orthopaedic surgeon is twenty patients per half day.
In order for physicians to be paid, insurance companies require the physicians to prepare specific individualized documentation for each patient. The guidelines and requirements for this documentation are strict, and significant financial and criminal penalties are possible if these guidelines are not followed. One set of guidelines is the Health Care Finance Administration guidelines (HCFA), which requires that a complete history be gathered and recorded on all patients. Medicare auditors reason that if a procedure is not documented, the procedure did not happen. Improper documentation may result in fines and a possible jail term.
Medical record documentation is required to record pertinent facts, findings and observations about an individual""s health history, including past and present illnesses, examinations, tests, treatments, and outcomes. The medical record chronologically documents the care of the patient and is an important element contributing to high quality care.
The patient encounter (the interaction between the physician and the patient which occurs, for instance, in a physician""s office) may be considered to be divisible into a number of segments: a history taking segment; a physical examination segment; a decision making segment, which includes the differential diagnosis phase, a diagnostic studies phase, a definitive diagnosis phase and a treatment plan phase; a documentation segment, which includes creating a record of the findings, decisions, and recommendations of the patient encounter; and a communication segment which includes sharing the documentation created during the patient encounter including reports, instructions, and requests.
Present systems and methods for capturing the information produced during a patient encounter rely heavily on dictation by the physician. This dictation may take as much as five minutes or more per patient encounter, so that the typical half day clinical session requires at least one hundred minutes of dictation by the physician. This dictation is done either between patient encounters, if there is time available, or at the end of the entire clinical session. In many cases the dictation must be done at the end of a physician""s working day, which is sometimes well beyond normal working hours.
The principles of documentation that follow are applicable to all types of medical and surgical services in all settings. For Evaluation and Management (E/M) services, the nature and amount of physician work and documentation varies by type of service, place of service and the patient""s status.
The levels of E/M services are based on four types of history (problem focused, expanded problem focused, detailed, and comprehensive). Each type of history includes some or all of the following elements: chief complaint (CC); history of the present illness (HPI); review of systems (ROS); and past family and/or social history (PFSH).
The chief complaint is a concise statement describing the symptom, problem, condition, diagnosis, physician recommended return, or other factor that is the reason for the encounter.
The history of present illness is a chronological description of the development of the patient""s present illness from the first sign and/or symptom or from the previous encounter to the present.
A review of systems is an inventory of body systems obtained through a series of questions seeking to identify signs and/or symptoms which the patient may be experiencing or has experienced. For purposes of review of systems, at least the following systems are recognized: constitutional systems (e.g., fever, weight loss); eyes; ears, nose, mouth, throat; cardiovascular; respiratory; gastrointestinal; genital urinary; muscular skeletal; integumentary (skin and/or breast); neurological; psychiatric; endocrine; hematologic/lymphatic; and allergic/immunologic.
The past, family and/or social history consists of a review of three areas: past history (the patient""s past experiences with illnesses, operations, injuries, and treatments); family history (a review of medical events in the patient""s family, including diseases which may be hereditary or place the patient at risk); and social history (an age appropriate review of past and current activities).
For purposes of examination, the following body areas are recognized: head, including the face; neck; chest, including breasts and axillae; abdomen; genitalia, groin, buttocks; back, including spine; and each extremity.
The extent of examinations performed and documented is dependent on clinical judgement and the nature of the presenting problems. They range from limited examinations of single body areas to general multi-system of complete single organ system examinations.
The levels of evaluation and management services recognize four types of medical decision making (straightforward, low complexity, moderate complexity, and high complexity). Medical decision making refers to the complexity of establishing a diagnosis and/or selecting a management option as measured by the number of diagnoses and/or the number of management options that must be considered; the amount and/or complexity of medical records, diagnostic tests, and/or other information that must be obtained, reviewed and analyzed; and the risk of significant complications, morbidity and/or mortality, as well as comorbidities, associated with the patient""s presenting problems, the diagnostic procedures and/or the possible management options.
The number of possible diagnoses and/or the number of management options that must be considered is based on the number and types of problems addressed during the encounter. The complexity of establishing a diagnosis and the management decisions that are made by the physician.
The amount and complexity of data to be reviewed is based on the types of diagnostic testing ordered or reviewed. A decision to obtain and review old medical record and/or obtain history from sources other than the patient increases the amount and complexity of data to be reviewed.
The risk of significant complications, morbidity, and/or mortality is based on the risks associated with the presenting problems, the diagnostic procedures, and the possible management options.
The extent of the history that is required for proper documentation varies according to the patient""s presenting problem. Certain conditions require a limited history, while other complaints are more involved and demand a more complete history. A complete history should include the patient""s chief complaint and the history of the present illness, a review of systems, and past medical, family, and/or social history. If a review of systems and/or a past medical, family, and/or social history have been documented earlier, the physician does not need to repeat this information. However, he or she should indicate that the previous information was reviewed and then updated, if appropriate. A review of systems and the past medical, family, and/or social history may be completed by ancillary staff or the patient. The record should include a note by the physician confirming the information that was documented by others and supplementing, as appropriate.
The type of physical examination that is performed depends upon the patient""s presenting problem and the physician""s clinical judgement. The examination may be limited to the affected area, or it may involve an entire organ system. The examination can be more extensive by detailing a complete multi-system examination. The guidelines defined 7 body areas and 12 organ systems for the purpose of physical examination.
The guidelines state that the medical record for a comprehensive, multi-system examination must contain the appropriate elements for at least 8 of the 12 organ systems noted. The guidelines do not require a complete examination of each of the organ systems involved in the examination.
The guidelines also state that specific abnormal and relevant negative findings associated with the affected body area should be documented and described. It is considered insufficient to note xe2x80x9cabnormal findingsxe2x80x9d in the medical record without elaborating on what those findings are.
FIG. 1 is a representation of a productivity flow diagram for a conventional physician/patient encounter. The patient encounter for patient 100 is divided into a history taking segment 120, a physical examination segment 122, an X-ray segment 124, a treatment plan segment 126 and a record segment 128. The history taking segment 120, the physical examination segment 122, and the treatment plan segment 126 requires the physician""s presence with the patient. The X-ray segment 124 does not require the physician""s presence with the patient, so that during the X-ray segment time, the physician may be attending to another patient.
The record segment 128 is generally done without the patient""s presence and requires the physician""s complete attention, so during the record segment 128 the physician is not engaged in direct patient care. The record segment is the only portion of the patient encounter that can be eliminated or shortened without decreasing time spent on direct patient care.
As can be seen in FIG. 1, a physician often overlaps patient encounters, so that while patient 100 is having an X-ray taken, the physician is attending patient 102 with the physical examination. Due to emergencies requiring the physician""s attention, the time between segments is variable and that the clinical session may be interrupted.
As a result of the conventional productivity work flow just described, the record segment is often required to be postponed until after the clinical session, at the end of the working day, in order for the physician to treat waiting sick and injured patients without intolerable delays.
Clinical information conventionally used for medical diagnosis includes ICD-9 (United States Department of Health and Human Services, National Center for Health Statistics, International Classification of Diseases, Ninth Revision, Clinical Modification) codes, epidemiology and demographics data, physical findings data, and epidemiology data. This data may also be used advantageously by the present invention to create a selective, specialty specific master database, as described below.
Pertinent clinical findings for representative diseases may be taken from standard references such as xe2x80x9cFerri""s Clinical Advisor,xe2x80x9d (Ferri, Fred F., Ferri""s Clinical Advisor-Instant Diagnosis and Treatment, 1st ed., Mosby-Year Book, Inc., 1999) the entire contents of which are hereby incorporated by reference. This standard data, an example of which is shown in Table 1, may be used advantageously to create a selective, specialty specific database, as described below.
Definition
An ankle sprain is an injury to the ligamentous support of the ankle. Most (85%) involve the lateral ligament complex. The anterior inferior tibiofibular (AITF) ligament, deltoid ligament, and interosseous membrane may also be injured. Damage to the tibiofibular syndesmosis is sometimes called a high sprain because of pain above the ankle.
ICD-9-CM Codes
945.00 Sprain, ankle or foot
Prevalence
1 case/10,000 people each day
Predominant Sex
Varies according to age and level of physical activity
Physical Findings
Often a history of a xe2x80x9cpopxe2x80x9d
Variable amounts of tenderness and hemorrhage
Possible abnormal anterior drawer test (pulling the plantar flexed foot forward to determine if there is any abnormal increase in forward movement of the talus in the ankle mortise)
Inversion sprains: tender laterally; syndesmotic injuries: area of tenderness is more anterior and proximal
Evaluation of motor function
Etiology
Lateral injuries usually result from inversion and plantar flexion injuries.
Eversion and rotational forces may injure the deltoid or AITF ligament or the interosseous membrane.
FIGS. 2, 3 and 4 are depictions of conventional diagnostic graphical user interfaces which have been used in home medical diagnostic systems. In these conventional systems the user typically displays a graphic image of the body or parts of the body and by using a pointing device, such as a mouse, can indicate the area of the body which is believed to be injured or part of the body in which the patient is experiencing discomfort. For instance, a patient with a leg injury will display the image of the leg on a computer screen and then further focus the diagnosis on a particular area of the leg where the patient is experiencing the most pain. In conventional systems these actions will then typically bring up more computer screens in which textual information is displayed which is used by the patient to further refine the diagnosis. The end result of this process is a diagnosis of the patient""s illness or injury, as well as suggested treatment options.
As recognized by the present inventors, the documentation and communication segments of the patient encounter under the present conventional methods and systems have at least the following drawbacks: they have become onerous for physicians; they are very time consuming; they are frequently performed after hours; they are often incomplete due to time constraints; they usually involve multilayered handling and delays in completion; information is not easily or remotely retrievable; and physicians frequently undercode for fear of government reprisals.
Although various electronic medical record systems currently exist, these systems have serious shortcomings. The present inventors have recognized that some limitations of existing systems are as follows: they are primary care based; they have unacceptable learning curves; they increase, rather than shorten, documentation time; they require additional computer skills; are text based, and have complex navigation schematics, have very expensive initial purchase, setup and maintenance costs; they have tool kits that are complex and are not end user friendly; they do not adequately address the xe2x80x9cAxe2x80x9d and xe2x80x9cPxe2x80x9d portions of the xe2x80x9cS.O.A.P.xe2x80x9d encounter model; they have unnecessarily large, non-selective databases; they are financially self-destructive; they are not suitable for multiple site, and multiple service practices; they ask too many irrelevant questions; and they are not self-learning. As a consequence, physicians spend too much time using these conventional tools, thus limiting the practical value of the tools.
The present inventors have recognized that an improved electronic medical records system includes the following characteristics: it saves physicians time; it has a minimum learning curve; it uses speciality specific databases; it uses simple tool kits, which allow end user modifications; it addresses all portions of the xe2x80x9cS.O.A.P.xe2x80x9d encounter model; the documentation produced integrates patient demographics, clinical information, E/M guidelines, treatment plans, reports, referral letters, prescriptions, coding, and HCFA compliance requirements; and it has reasonable startup and maintenance costs.
Selected features of the inventive system include:
graphics/icon modulated schematics;
selective, speciality-specific, master databases;
anatomic specific, secondary databases and templates;
diagnosis specific, prepopulated templates for E/M documentation, x-rays, diagnostic studies, prescriptions, and reports;
drilldown and rollup logic;
end-user modifiability;
text and voice recognition enablement, at each level of data abstraction;
image capture enablement; and
digital x-ray enablement.
Significant efficiencies in the documentation process can be achieved by an innovative application of xe2x80x9cbottom-upxe2x80x9d reasoning and backward-chaining, proceeding from a diagnostic conclusion to the clinical findings that are most probably linked with the diagnosis. The present inventors have further recognized that an experienced clinical specialist can quickly arrive at a highly probable diagnosis within a few moments of encountering the patient. According to the present invention, this clinical expertise is used to enable efficient documentation production by allowing the physician to use diagnostic specific templates, with pre-populated default values for diagnosis analysis steps, to logically structure the documentation production process. Unnecessary physician input is thereby eliminated, since the default values, which may be overwritten by the physician if appropriate, are already selected, so that the documentation process can be completed concurrently with the patient encounter.
The present invention achieves the following advantages over existing electronic medical record systems.
The present invention saves physicians time.
The present invention eliminates the lengthy data entry process required by current electronic medical record programs.
The present invention eliminates most dictation, multiple reports, written prescriptions for medications, diagnostic studies and physical therapy, the manual completion of forms, and separate sources for patient education materials.
The present invention saves physician staff time.
The present invention eliminates the need for transcription, filing, report composition, and chart retrievals.
The present invention saves the practice money. The present invention decreases staffing requirements, with considerable overhead reduction.
The present invention achieves major savings for software companies by reducing the technical staff needed for system startup and future system support.
The present invention produces complete and thorough documentation that is comprehensive, accurate, and compliant.
The present invention improves patient flow.